Thomas Conroy, RPh., J.D. Director, Promotion Compliance Global Regulatory Affairs MARCH 11, 2015

Transcription

1 Thomas Conroy, RPh., J.D. Director, Promotion Compliance Global Regulatory Affairs MARCH 11, 2015

2 All slides and accompanying comments, ideas, arguments and other statements of any kind are personal to the speaker and are not attributable to any company, entity and/or individual. Consult your firm s regulatory and legal experts in compliance with your company s policies and procedures to determine the approach that s right for you.

3 When will a mobile app be regulated as a medical device? FDA MEDICAL DEVICE OVERVIEW FDA GUIDANCES Mobile Medical Apps (2/9/2015) General Wellness: Policy for Low Risk Device (1/16/2015) How mobile device size and space requirements impact fair balance requirements? Traditional FDA rules apply- techniques Internet/Social Media Platforms with Character Space Limitations Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices Strategies for engaging and impactful mobile content with regulatory requirements and guidance Unbranded Considerations Character/space limits

4 FDA MEDICAL DEVICE OVERVIEW FDA GUIDANCES

5 Medical Device definition FDCA Intended Use Three classes of devices & market entry

6 A medical device is an instrument, apparatus, implement, machine, contrivance... or other similar or related article, including any component, part, or accessory INTENDED for use in the diagnosis, treatment, cure, or prevention of a disease or condition, or intended to affect the structure or function of the body which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes (Reference Section 201(h) of FD&C Act, [21 U.S.C. 321(h)]) 6

7 INTENDED USE refers to the objective intent of the persons legally responsible for marketing the product, & is shown by: Labeling (e.g., product packaging, end-user manuals, medication guides, other info that is integral to a transaction or necessary to ensure safe use of the product) Promotional Statements (e.g., ads or other activities that raise awareness of a business or product; also, surrounding content/graphics are important factors) Other Statements Made By or On Behalf Of the Marketer (e.g., securities filings, patent filings, testimonials, oral statements by sales reps, depictions of conduct or use) Actual Knowledge of the marketer as to end user intent; circumstances of marketing [Reference 21 C.F.R ]

8 Class I (low risk) Most are exempt from premarket authorization by regulation [21 C.F.R (c)(1)] To qualify for exemption, the product must match the classification regulation [21 C.F.R. Parts ] If device s characteristics, intended use, or claims are outside the scope of the classification regulation, then premarket authorization is required Class II (moderate risk) Typically, manufacturer or sponsor must submit an application demonstrating that product is substantially equivalent to a previously marketed (predicate) device; clinical trials sometimes, but not always, required 21 C.F.R. Part 807, Subpart E Class III (high risk) Typically, manufacturer or sponsor must submit a PMA with clinical trial data showing that product is safe and effective for its intended use See generally, 21 C.F.R. Part 814

9 Mobile Medical Apps (MMAs-G) Guidance for Industry & FDA Staff (February 9, 2015) General Wellness: Policy for Low Risk Devices (GW-G) Draft Guidance for Industry & FDA Staff (January 16, 2015)

10 Guidance for Industry & FDA Staff (MMAs-G) February 9, 2015

11 Recent Guidance (2/9/2015) does not substantively change the 9/25/2013 guidance Guidance described the subset of mobile apps that FDA intended to regulate, & provided an overview of the medical device requirements & regulations that apply to MMAs. Most of the updates in the 2015 Guidance are located in Appendices, providing examples of: (1) apps that are not medical devices; (2) apps for which FDA intends to exercise enforcement discretion; and (3) MMAs that FDA intends to regulate as medical devices.

12 Mobile App- software app used on a mobile platform - or - a web-based software app tailored for use on a mobile platform but executed on a server. Mobile Platform commercial off-the-shelf (COTs) handheld computing platform, without regard to wireless connectivity capabilities or not. Examples: PDAs, tablets, and smart phones.

13 A mobile medical application (MMA) is a mobile app that (1) meets definition of device in 201(h) of the FDCA and (2) Either (a) Is used as an accessory to a regulated medical device; - or - (b)transforms a mobile platform into a regulated medical device FDA will not exercise authority over: apps that are not medical devices under Sec. 201(h), - NOR - will it enforce its rules and regulations against the numerous apps that: meet the definition of medical devices but present only MINIMAL RISK to consumers or patients.

14 Specifically, MMAs are mobile apps that: are an extension of one or more medical devices by connecting to device(s) for purposes of controlling device(s) or for use in active patient monitoring or analyzing medical device data; transform mobile platforms into regulated medical devices by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices; or become regulated medical devices (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations.

15 FDA intends to not enforce FDCA requirements for MAs that: Help patients self-manage their disease or conditions without providing specific treatment or suggestions; Provide patients with simple tools to organize and track their health information; Provide easy access to information related to patients health conditions or treatments; Help patients document, show, or communicate potential medical conditions to health care providers; Automate simple tasks for health care providers; Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems; or Intended to transfer, store, convert format, and display medical device data in its original format from a medical device (as defined by MDDS regulation OUG).

16 Library of clinical descriptions Medical flash cards Certification or recertification preparation apps; Games to train health professionals in advanced CPR skills. Pill ID: Allow users to input pill shape, color or imprint and displays pictures and names of pills that match this description; Find the closest medical facilities; Help guide patients to ask appropriate questions to their HCP Track, review and pay medical claims and bills online; Manage or schedule hospital rooms or bed space

17 Draft Guidance for Industry & FDA Staff (GW-G) January 16, 2015

18 FDCA DEFINITION: if the device is not intended to cure, treat, diagnose a condition or disease, but is for general health use, then it is not regulated. INTENDED USE: if a device is intended to promote a healthy lifestyle or associate a healthy lifestyle to reduce the impact of certain diseases, then it is generally considered not regulated. FUNCTIONALITY: even if the device captures physiological parameters for display, if the intent is not to diagnose a condition but to track body activity in the context of fitness (and not a disease), then it is also not regulated.

19 Per FDA, a general wellness product has: (1) An intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, - Or (2) An intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

20 General Wellness Claim: Intended use involves claims for sustaining or offering general improvement to conditions and functions associated with a general state of health without making any reference to diseases or conditions. Not a General Wellness Claim Promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals A claim that a product will treat or diagnose obesity; or will treat anorexia Promote relaxation or manage stress without A claim that a product helps treat reference to anxiety disorders or other reference to a anxiety disease or condition Improve mental acuity, instruction following, concentration, problem solving, multitasking, resource management, decision-making, logic, pattern recognition or eye-hand coordination Promote physical fitness, such as to help log, track, or trend exercise activity, measure aerobic fitness, improve physical fitness, develop or improve endurance, strength or coordination, or improve energy A claim that a computer game will diagnose or treat autism A claim to restore a structure or function impaired due to a disease, e.g., a claim that a prosthetic device enables amputees to play basketball.

21 The second category* of general wellness intended uses is comprised of two subcategories : 1) intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; (e.g. A product that helps track fitness goals may be promoted as helping to reduce the risk of heart disease.) - and - 2) intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions. (e.g. heart disease, high blood pressure, and type 2 diabetes) * These claims should only reference a disease where it is medically well understood that healthy lifestyle choices may reduce the risk or impact of a medical condition.

22 A mobile app may become a regulated MMA based on: INTENDED USE in the diagnosis, treatment, cure, or prevention of a disease or condition, based on objective statements (labeling, ads, etc.) that suggest or imply disease treatment, etc.; - and/or - Connecting/controlling a regulated medical device; - and/or - Performance of patient-specific analysis and provision patient-specific diagnosis, or treatment recommendations - and Not excluded from Reg compliance by FDA enforcement discretion because it s more than low risk to patient safety; - or - Not considered a General Wellness Product.

23 Traditional FDA rules apply- suggested techniques Internet/Social Media Platforms with Character Space Limitations Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

24 FDA regulates labeling (e.g., instructions for use, etc.) for all medical devices and advertising of restricted medical devices Labeling definition is broad and may encompass many forms of advertising FTC regulates advertising of non-restricted devices Focuses on deceptive advertising/trade practices (e.g., false statements, omitting material facts, misleading practices) Takeaway message for industry sponsors: FDA rules will probably apply for most mobile medical apps (MMAs) Rx drug messaging displayed on MMAs OPDP ad/promo rules apply (fair balance, PI, ISI, etc.) MMA functional display content: FDA/CDRH labeling rules Messages about MMAs: FTC advertising rules apply

25 Must be truthful and non-misleading (FD&C Act sections 502(a), 201(n)). Benefit claims must include certain information, such as the product indication and the risks associated with use of the product (21 CFR (d)). Must present a fair balance between information relating to risk and information relating to benefit (21 C.F.R (e)(5)(ii)) Risk information must be presented with a prominence &readability reasonably comparable to claims about drug benefits. (21 C.F.R (e)(7)(viii)); *Must submit materials to FDA (Form time of 1 st use

26 Must contain risk information in each part, as necessary, to qualify any representations and/or suggestions made in that part about the drug. The risk information may be concise if supplemented by a prominent reference to the presence and location elsewhere in the advertisement of a more complete discussion (21 C.F.R (e)(3)(i)) Must reveal facts that are material with respect to possible consequences of the use of the product as represented in the labeling or advertising or under conditions of use that are customary or usual. (21 CFR 1.21) Reminders, mentioning names of products without representations or suggestions about the products, are exempt from many labeling and advertising disclosure requirements (21 CFR , (f), 202.1(e)(2)(i)).

27 Utilize scrolling in order to view the complete ISI effectively. Use of a static tab or link to full ISI and or PI Use of headlines and signaling use signals such as continued more and select Also, consider using if safety information continues from page-to-page based on the smaller footprint and displays available in mobile platforms.

28 Draft Guidance for Industry June

29 Describes current thinking about how sponsors that choose to present benefit information should present both benefit and risk information (balanced) within promotion on Internet/social media platforms with character space limitations Online microblog messages (e.g., Twitter) Online paid search (e.g., Google or Yahoo sponsored links ) Future character-spacelimited Internet/social media platforms (longterm applicability) Product websites Webpages on social media networking platforms (e.g., individual product webpages on Facebook, Twitter, YouTube) Online web banners Responsive web design or other technology-specific presentations (e.g., mobile devices, tablets) Within scope of guidance Outside scope of guidance

30 CHALLENGE: FDA recognizes communication on Internet sites with character space limitations can be challenging. RESPONSIBILITY/BALANCE: Regardless of character space constraints that may exist on certain Internet/social media platforms, if a sponsor chooses to make a product benefit claim, the sponsor should also incorporate risk information within the same character-space-limited communication. LINKS TO RISK INFO: The sponsor should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product. COMMON ABBREVIATIONS: acceptable to use as well as URL shortening services * Drugs/GuidanceComplianceRegula toryinformation/guidances/ucm pdf 30

31 FDA recommends that firms: Carefully consider the complexity of the indication and risk profiles for each of their products to determine whether a characterspace-limited platform will enable meaningful presentations of both benefit and risk information. Then, take the factors, recommendations, and hypothetical examples outlined in this draft guidance into account when developing benefit and risk presentations. 31

32 Unbranded Considerations Character/space limits

33 Unbranded materials on MMAs Unbranded banner links to branded content (e.g. website) when possible Unbranded Mobile Apps E.g. create General Wellness mobile app related to, but not connected to, a promoted approved product owned by the sponsor of both. POINTS TO CONSIDER: If an unbranded tactic is selected, be mindful of the major aspects of the FDA Guidance: Help- Seeking/Disease Awareness (February 2004) temporal separation and graphic distinction

34 Improve: Outcomes Monitoring Care Diagnosis Treatment Helps stabilize Prevention Disease related Better More Less Fewer Just like Easier than Smartest Unmatched Advanced Equal to Comparative Terms

35 OPPORTUNITY: Existing Mobile Medical Device (e.g. electronic health records (EHRs), e-prescribing platforms for HCPs, etc.) Sponsor wants to communicate about an approved prescription drug to the device user Access permitted by platform owner has finite space limitations for sponsor to purchase for desired messaging. SUGGESTIONS: If possible, based on product risk info in PI: follow traditional FDA Rules (fair balance, etc.), make use of enhanced technology (scrolling text, pop-ups, etc. for Important Safety Information [ISI] & Select ISI), & utilize FDA Social Media Guidance tenets where possible or by analogy when needed for new media with space limits.

36 THANK YOU for your attention.

37

38 Draft Guidance for Industry June

39 Describes current thinking about how sponsors that choose to present benefit information should present both benefit and risk information (balanced) within promotion on Internet/social media platforms with character space limitations Online microblog messages (e.g., Twitter) Online paid search (e.g., Google or Yahoo sponsored links ) Future character-spacelimited Internet/social media platforms (longterm applicability) Product websites Webpages on social media networking platforms (e.g., individual product webpages on Facebook, Twitter, YouTube) Online web banners Responsive web design or other technology-specific presentations (e.g., mobile devices, tablets) Within scope of guidance Outside scope of guidance

40 CHALLENGE: FDA recognizes communication on Internet sites with character space limitations can be challenging. RESPONSIBILITY/BALANCE: Regardless of character space constraints that may exist on certain Internet/social media platforms, if a sponsor chooses to make a product benefit claim, the sponsor should also incorporate risk information within the same character-space-limited communication. LINKS TO RISK INFO: The sponsor should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product. COMMON ABBREVIATIONS: acceptable to use as well as URL shortening services * Drugs/GuidanceComplianceRegula toryinformation/guidances/ucm pdf 40

41 Benefit information should be accurate and nonmisleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet). Benefit information should be accompanied by risk information within each individual character-space-limited communication. If a sponsor concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-spacelimited communication, then the sponsor should reconsider using that platform for the intended promotional message as it may not provide meaningful presentations of both benefit and risk particularly for products with complex indications or extensive serious risks. 41

42 RISK/BENEFIT: Risk info should be presented together with benefit information within each individual character-space-limited communication (each individual message or tweet). MOST SERIOUS RISK INFO: Content of risk info presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with product. HYPERLINK: A mechanism, such as a hyperlink, should also be provided within each individual character-space-limited communication to allow direct access to a more complete discussion of risk information about the product. COMPARABLE PROMINENCE (FAIR BALANCE): The prominence of risk information should be comparable to the benefit information within each character-space-limited communication, taking into consideration any formatting capabilities available on the specific Internet/social media platform. 42

43 Many Internet/social media platforms allow the use of uniform resource locator (URL) shortening services, which are likely to result in a URL or web address with fewer character spaces. FDA does not intend to object to the use of such URL shortening services; however, when possible, the Agency recommends that the URL or web address itself denote to the user that the landing page consists of risk information (e.g., If the URL or web address itself is promotional in content or tone, FDA may take into consideration whether any resulting claims are false or misleading or provide evidence in support of other violations under the FD&C Act and FDA s implementing regulations (e.g., a URL such as may be misleading). 43

44 FDA does not intend to object to the following: Communicating the established name directly to the right of, or directly below, the proprietary name within the character-space limited communication Substituting commonly recognized linguistic symbols for words Using punctuation marks to help with the presentation of information Denoting a chemical ingredient name with a scientific abbreviation 44

45 FDA recommends that firms: Carefully consider the complexity of the indication and risk profiles for each of their products to determine whether a characterspace-limited platform will enable meaningful presentations of both benefit and risk information. Then, take the factors, recommendations, and hypothetical examples outlined in this draft guidance into account when developing benefit and risk presentations. 45

46 Draft Guidance for Industry & FDA Staff (GW-G) January 16, 2015

47 FDCA DEFINITION: if the device is not intended to cure, treat, diagnose a condition or disease, but is for general health use, then it is not regulated. INTENDED USE: if a device is intended to promote a healthy lifestyle or associate a healthy lifestyle to reduce the impact of certain diseases, then it is generally considered not regulated. FUNCTIONALITY: even if the device captures physiological parameters for display, if the intent is not to diagnose a condition but to track body activity in the context of fitness (and not a disease), then it is also not regulated.

48 Per FDA, a general wellness product has: (1) An intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) An intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

49 General Wellness Claim: Intended use involves claims for sustaining or offering general improvement to conditions and functions associated with a general state of health without making any reference to diseases or conditions. Not a General Wellness Claim Promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals Promote relaxation or manage stress without reference to anxiety disorders or other reference to a disease or condition Improve mental acuity, instruction following, concentration, problem solving, multitasking, resource management, decision-making, logic, pattern recognition or eye-hand coordination Promote physical fitness, such as to help log, track, or trend exercise activity, measure aerobic fitness, improve physical fitness, develop or improve endurance, strength or coordination, or improve energy A claim that a product will treat or diagnose obesity; or will treat an eating disorder, such as anorexia A claim that a product helps treat anxiety A claim that a computer game will diagnose or treat autism A claim to restore a structure or function impaired due to a disease, e.g., a claim that a prosthetic device enables amputees to play basketball.

50 The second category* of general wellness intended uses is comprised of two subcategories : 1) intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; (e.g. A product that helps track fitness goals may be promoted as helping to reduce the risk of heart disease.) - and - 2) intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions. (e.g. heart disease, high blood pressure, and type 2 diabetes) * These claims should only reference a disease where it is medically well understood that healthy lifestyle choices may reduce the risk or impact of a medical condition.